Loading clinical trials...

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE2

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

NCT06953089•DualityBio Inc.

View on ClinicalTrials.gov

Summary

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Detailed Description

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants. Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
•At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
•Has a life expectancy of ≥ 3 months.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
•Has adequate organ function within 7 days prior to enrollment/randomization,
•Has adequate treatment washout period prior to the first dose of trial treatment.
•* For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.
•* For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology
•* For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
•* For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease.
+2 more criteria

Exclusion Criteria

•1\. Prior treatment with B7H3 targeted therapy.
•Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
•Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
•Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
•Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.
•Has a history of (non-infectious) ILD/pneumonitis.
•Any autoimmune, connective tissue or inflammatory disorders.
•Has spinal cord compression or clinically active central nervous system (CNS) metastases.
•Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.

Locations (37)

USA06-0

Los Angeles, California, United States

USA16-0

Los Angeles, California, United States

USA01-0

Wheat Ridge, Colorado, United States

USA08-0

Florida City, Florida, United States

USA10-0

Atlanta, Georgia, United States

USA11-0

Bethesda, Maryland, United States

USA14-0

Lincoln, Nebraska, United States

USA04-0

New York, New York, United States

USA15-0

Portland, Oregon, United States

USA03-0

Charleston, South Carolina, United States

Key Dates

Start Date

July 18, 2025

Primary Completion Date

June 30, 2030

Completion Date

June 30, 2030

Last Updated

February 6, 2026

Enrollment

492

ESTIMATED participants

Conditions

Solid Tumors

Interventions

DB-1311/BNT324

DRUG

BNT327

DRUG

DB-1305/BNT325

DRUG

Contacts

Jay Ma

CONTACT

540-808-3925 jay.ma@dualitybiologics.com

Qiaoli Jiang

CONTACT

+86-15210642683 qiaoli.jiang@dualitybiologics.com

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors